CA1179944A - Composition for temporary substitution of bone tissue defects - Google Patents
Composition for temporary substitution of bone tissue defectsInfo
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- CA1179944A CA1179944A CA000404906A CA404906A CA1179944A CA 1179944 A CA1179944 A CA 1179944A CA 000404906 A CA000404906 A CA 000404906A CA 404906 A CA404906 A CA 404906A CA 1179944 A CA1179944 A CA 1179944A
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- bone
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- composition
- cyanacrylate
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Abstract
A b s t r a c t The present invention relates to medicine and, more particularly, to a composition for a temporary substitution of bond tissure defects.
The composition according to the present invention comp-rises .alpha.-cyanacrylic acis esters and a powder-like filler which is a calcium salt of an organic or an inorganic acid with a praticle size of from 0.01 to 0.5 mm at the following proportions of the components, per cent by weight:
.alpha.-cyanacrylic acid ester 60 - 40 calcium salt of organic or inorganic acid with a particle size of from 0.01 to 0.5 mm 40 - 60.
The composition according to the present invention is useful in fixation of bone fragments, fixation of bone homo-transplantant in the case of anterior cervical spondyolodesis, temporary filling of bone cavities and the like.
The composition according to the present invention comp-rises .alpha.-cyanacrylic acis esters and a powder-like filler which is a calcium salt of an organic or an inorganic acid with a praticle size of from 0.01 to 0.5 mm at the following proportions of the components, per cent by weight:
.alpha.-cyanacrylic acid ester 60 - 40 calcium salt of organic or inorganic acid with a particle size of from 0.01 to 0.5 mm 40 - 60.
The composition according to the present invention is useful in fixation of bone fragments, fixation of bone homo-transplantant in the case of anterior cervical spondyolodesis, temporary filling of bone cavities and the like.
Description
Title of the Invention CCMPOSITIO~ ~OR T~POR.~.RY SUBSTITUTION 0~ BO~E TISSU~ DEPFCTS
~ield of the In~ention The present invention relates to medicine and, more spe-cifically, to a co~lposition for a temporary substitution of bone tissue defects. The composition is useful both individu-ally or in combination ~ith an ultrasonic treatment for the fixation of bone r~g~ents, fixation of bone homotransplantant at anterior cervical s oncylosis, tenpor-:ry fillin~ of bone cavities, reccvery of articular surfaces, fi~ation of on-bone implanted Pctive electrodes for a subsequent electrostimula-tion of osteo~enesis and the like.
BacXground of the Invention inown in the art are compositions for a temporary substi-tution of defects of bone tissue w~ich are based on ~-cyana-crylates and fillers, e.g. a com~,osition corrlprising ethyl-- ~ -cyanacrylate and bone chips. (In coll. "Osteosynthesis, 30ne Welding and CuttinF of ~ive Biolo~ical Tissues by Ultr~-sonic Wave Guides", ~09COW, 1970, p. 12-15, "Grthopedics, Trawn~tology and rrosthetics", Moscow, 1975, I~o. 10, p.18-23).
In prnctical use of this prior art con,position bone chips are placed onto a ~one substrate re,~aining after resection, added with ethyl- ~ -cyanacrylate Pnd under the effect of ultr~sonic treatrrJent the composition ic transforlned into a solid con~lomerate temporarily substitutin~ the bone defect.
The composition comprises 50~ by ~eight of bone chips and 50% by weight of ethyl- ~ -cyan-acrylate. 30ne chip~ compri-se an active co~ponent relative to ethyl- ~ -cyanacrylate and /
11'79944 cau~es ~n instant curing of the latter. Thi8 does not enable a preci~e metering of amounts of the components, formation of a homogeneous composition whlch, in turn, re~ults in instsble durability characteristics.
Purthermore, bone chips get rapidly impregnated with ethyl- d~-cyanacrylates ~hich results in the formation Or a monolithic conglomerate hindering regeneration of bone ti89ue.
Also known in the art i8 a composition containing 70-50~
by weight and 30-50% by ~eight of bone chips with its particles coated with an envelope of a non-toxic, ~ater~soluble and inso-luble in ethyl- ~ -cyanacrylate polymer - dextrane (cf. Veden-kov V.G., Akimova A.Ya., Bukhtiarova G.Y~., Derkach G.M., Cys' I.N. "Development of a composition for ultrasonlc welQing and meltlng-on of bone tissues baYed on modified bone shavings and ethyl-o~-cyanacrylatet'. Ultra sound and other kinds of energy in ~urgery. ~oscow, 1974, p.62-66).
Coating of particles of bone chips ~ith an envelope of a polymer soluble in water and insoluble in ethyl- ~ -cyan~-crylate hAs made it possble to ensure a more precise dosage of the components, reduce monolithic chhr~cter of the forming conglomerate.
However, the use of bone chips in the composition does not make it pos~ible to obtain a uniform blend after mi~ing of th~ components. ~or thi~ reason in the cured conglomerate there can be formed zones with an incr~fised content of bone chip~ and zones consi~ting essentially of polyethyl- ~ -cya-nacrylate. The distribution of the component~ in the cured con-glomerate affects the speed of it~ destruction under the effect of the arganism media which, in turn, ca~ slo~-down the speed of regeneration of bone tis~ue. Therefore, in the use Or modi-fted bone chips a~ 8 filler it i8 impo~sible to obtain stable reproducible re~ults as regards the ~peed o~ biodestruction of the conglomerate.
The disadvantage of the above-mentioned composition also resides in that bone chips compri~e an e~pensive product not suitable for stand~rdization. Furthermore, the use of ethyl-- ~ -cyanacrylste in this compo~ition re~ults i~ the ~ormation o~ a conglomerate resi~tant to the effect of the organism me-dia and it~ biodestruction proceeds but 810wly, wherefore the conglomerate hinders regeneration of the newly formed bone tl-ssue. In view of the above-listed disadvantages thie compo~i-tion hQs not found any suitable application in practical medi-cine.
Summsry Or the Invention It i~ an object Or the present invention to provide ~
composition for Q temporary substitution of bone tissue defects ~hich would be useful in mediacl practice and enabling reduced time of biodestruction of the cured conglomerate, thus provld-ing favourable condition~ for regeneration of bone tissue and reducing the time of treatment and rehabilitation of patients.
This object i~ Accomplished by that the compo~ition for a temporary ~ubstitution of bone ti~ue defect~ on the basls of ~ -cyanacrylic acid e~ters and a filler, according to the pre~ent invention, contains a powder-11lce filler - a salt of Galcium of an organic or inorganic acid with a particle 8~ ze of from 0.01 to 0.5 mm, the components being pre~ent in the following proportions, per cent by ~eight: -~-cyanscrylic acid esters 60 to 40 calcium ~alt of organic or inorganic acid with a partlcle size of 0.01-0.5 mm 40 to 60.
As calclum ~alts of organic or inorganic acids the compo-~ition according to the present invention caD incorporate cal-cium carbonate, calcium gluconste, calcium chloride, calcium phosphate, calcium citrate. It i8 preferable that the compo~i-tion would cont~in calcium gluconate or calcium carbonate. To impart a predetermined physiological effect to the prepara-tion, it should be a~ded with regeneration stimul~nte and anti-~eptics.
The r,reparation according to the preYent invention prefe-rably contains, as a regeneration stimulant, 4-uracylcarboxy-lic acid (orotic acid) or its derivatives in an amount of from 10 to 30% by weight.
A~ the anti~eptic the composition accordin~ to the present invention preferably incorporate~ 1,4-di-N-oxy ~,3-dlhydro~y-methylquino~aline or 1,4-di-N-oxy 2,3-d;aceto~ymethylqulno~a-line in an amo~nt of from 10 to 3~0 by weight.
A~ the composition base intended for the provisi~n of adjusted time limits of biodestruction Or the cured conglomera-te, it i8 preferred to use a nixture of ethyl- J~-cyanacrylate and etho~yethyl- ~-cyanacrylate, the componentQ being pre6cnt in the following proportions, per cent by weight:
ethyl- ~ -cyanacrylate 80 to 95 etho~yethyl- ~cyanacrylate 20 to 5.
Detsiled De~cription of the Invention The composition i8 prepared directl~ before u~e by mi~ing the compos~tion component~ at room temperature in a polyethy-lene or fluoropla~t~c vessel. After l~ixing Or the component~
paste-like mas~ 19 formed which ha~ sdherence to the bone ti~ue. The life time of the compo~ition ran&e~ ~ithin 5 to 30 minutes depending on the employed calcium salt and propor-tion~ of the components.
The p&ste-like m~ss i8 applied onto a preliminarily dried surface of the bone tissue. To accelerate the process of curing of the composition u~e can be n,ade of an ultrasonlc treatment (amplitude ~0-55Jum, frequency 26.5 kHz, treatrnent time 30-60 3econds ) .
Curing o~ the composition by the effect of ultra sound occurs within 1-2 minutes, without ultrasonic treatment - with-in 5 to 30 minutes. The u~e of calc~um ~alt in the composition according to the present ~nvention as a filler ~laXea it possib le to pro~uce ~ uniform mixture after blending of the conlpo-nents uhich, in turn, en~ures reproducible dats as regards the ~l~ed of b~odestruction of the cured conglomerate.
The u~e of the composition containing a calcium salt and a mixture of ethyl- and etho~yethyl- ~ -cyan&crylate makes it possible to reduce the duration of biode~truction of the cured con~lomerate by 0.8-2 times as co~pared with the co~iposition incorporating bone chip~ 6nd ethyl~ cyanacrylste.
To lncrease hydrophillc power of the composition, partic-les of the salt of calcium can be coated with envelopes of R
non-toxic polymer soluble in ~ater and in~oluble in ~ cyana-11799~4 crylates.
As the ~alts Or calcium use can be m de of different orga-nic and inorganic c81cium salts such as calcium carbonste, calcium chloride, calcium phosphate, calcium citrate, calclum gluconate and the like.
hs the regeneration stimulants use i8 made Or 4-uracyl-carbo~ylic scid, potassium salt of 4-uracylcsrbo~ylic acid and the like. As antiseptics use c~n be made of antibiotics or such compounds a~ 1,4-di-~-oxide 2,3-dihydroxymethylquino~a-line, 1,4-di-N-o~y 2,3-diaceto~ymethylquino~aline. The regene-ration stimulants and antiseptic~ are introdiced in an ~mount ranging from 10 to 30% by weight.
The composltlon according to the present invention has no toxic e~fect, ensures a lasting evolution of the regeneration stimulants into thetrauma zone, ret~inc bactericidsl proper-ties within 2-3 ~eek~ after the operation and provides no hindering effect on regeneration of the bone tissue.
The compo~ition for a temporary substitution of bone tis-sue defects h~s been tested in clinics on 200 patients. The composition is prepared right betore use and applied onto pre-liminarily drled surface of a bone ti~aue. The composition has thus ~een tested.
~ or filling of bone cavities in radical operations on patients suffering from chronical osteomyelitis including ~houlder osteomyelitis, femor~l osteomyelltis, tibial osteo-myelitis, i~hiatic osteomyelitis. In all c~se~ there i~ ob-serYed nealiDg of--wounds by primary e~tension; no compl~cations associated with the use of the composition according to the ~179944 pre~ent invention are observed.
The use of the composition according to the present in vention make~ it possible to avold drainaæe.
In reconstruction operations of ~rongly consolidated frac-tures, rheumatic polyarthritis, for fixation of bone fragment~
of forearm, peroneal bone, shinbone, collar bone, fixation of bone transplantant~ ~ith the use of the composition of this invention heali~g occured without complications. In none of the cases a~y secondar~ di~placement ~as observed.
In fi~ation of bone grafts to prevent micro- and macro-shiftings in reconstruction steps of osteoplastic operations of chronical otitis med~a, non-purulent disease of middle ear, chronical diseases of nasal sccessory sinuses, ma~i,llary sinus cyst, ethmoidal sinus osteoma with the use of the compo~ition according to the present invention no complications were ob-served. The use of the composition made it possib1e to reduce the duration of ~tay of the patients in the hospital by 4-6 days, as uell as to ensure a strict restoration of anatomic reliefs which is e~pecially important froln both functional and cosmetic standpoint. The composition accor~ing to the pre~ent lnvention ha~ been also tested for fixation of on-bone implan-ted electrodes for carrying out electrostimulation, as well as for fixation of ~one homotransplantant at a~terior cervical spondyoledosis.
The use of the composition acsording to tbe present in-vention has made it possible to avoid an externsl fixation of the cer~ical part of spin~l column thu~ ~llowing an early ac-tivization o~ patients. The dur&tion of ~tsy of the patients ~79944 ~n hospitEl W2S reduced b~ 2 wee~s~ No shiftings and compli~
cations due to the use of the composition were observed.
~ or a better understan~ing of the p~esent inve~tion some specific examples illustratinO the co~posi~,ion for a tempora~
r~ subs~itution of defects of bone tissue are ~iven hereln~
belo~.
Ji.ample A composition for a temporary sub~,titution of' bone tis-sue defects consists of the follo~ing componentC~ per cent by ~,eight:
cc~lcium carbona~e ~ith a par~icle size of from 0.01 ~o 0.05 mm 50 ethyl~ ~ ~cyc?n2crylate 45 ethoxyethyl~ ~ -cyanacrylate 5 ~ sterile ~eighed portion enc2psulated in de}~rane, m-'x~
ed ~ith ~ -cyan~crylic ~cid esters till the formation of a paste-like mass. ~he cohesion strength of the cured conglome~
rate determined on the instrument Dins~et Dis (ultimate bend-:ng strength) is 200 to 250 kg/cm . ~he sc~mple weight decre~se after the residence in ~ater at the ter~perature of 37C for 28 d~ys is 8,~ he composition is in-tc-n~ed for fi~c?tion of bone fragments~ bone transplantant, securing of on-bone imp~
lanted active electro~es.
~ -am~le 2 ~ co~.,.,os-tion ~or a ter~pora y su'~stitution of bone tis~
sue defects con~ists of ~he follG~ing co-~Gnents, per cent b~- weight:
calcium gluconate with a particle size of from 0~05 to 0.2 mm 60 1~7994~
.
ethyl- ~ -cyanscrylate 3~
etho~yethyl- ~ -cyanacrylate 8.
A ~terile weighed portion of calcium gluconate i8 mi~-ed with ~-cyanacrylic acid ester3 to obtain a paste-like ma~. The cohesion ~trength of the cured conglomerate deter-mined on the in~trument Dinstat Dis (ultimate bending strength i~ 230-250 kg/cm2. The sample weight decr~ase after residence in water at the temperature of 37C for 28 days i~ ~0%. The composition ~s inten~ed for fixation of bone framents, bone transplantant~, securing of on bone implanted acti~e elect-rodes, restorstion of articular surfaces.
Example 3 A composition for a temporary ~ub~titution of bone tis-~ue defects consist~ of the following components, per cent by weight:
disubstituted calcium orthophosphate 60 ethyl- ~ -cyanacrylate 40.
The composition i8 prepared follo.~.in~ the procedure si-milar to that described in Example 1 hereinbefore. The cohe-sion strength RS determined on the in~trument Dinstat Dls ~ultimate bending strength) is 250-280 kg/cm2. The sam~le weight decrease after residence in water at the temperature of 37C ~or 28 days i~ 5%. The compo~ition ls intended ior fixation of on-bone implanted actiYe electrodes, restorat~on of ~rticular surfaces.
Example 4 A compo~it~on for a temporary ~ubstitution of bone tis-sue defect~ Gonsi~ts of the ~ollowing cimponents, per cent 117g94~ ' b~ weight:
calcium gluconate 20 potassium sHlt of 4-urscyl-carbo~ylic ac~d . 20 ethyl- d -cganacrylate 40 ethoxyethyl- ~ -cyanacrylate 10.
The compo~itlon i8 prep~red in a msnner simllar to that described in E~ample~ 1 and 2. The conhesion strength of the cured.conglo~erate determined on the lnstrument Din~tat-Di~
is 200 to 220 kg/cm2. The sample u-eight decrease after re~i-dence ln water for 28 dPya st the temperature of 37C is 20%.
The composition i8 intended ror fixation of electrodes, re~-toration of articular surraces~ fi~ation of bone homotrans-plantants in the case of anterior cervlc~l spondyoledo~ 8.
Example 5 - A compo~ition for a temporar~ ~ub~titution of bone ti8-sue defects con8i8t8 of the ~-ollowing components, per cent by welght:
calcium carbonate 30 1,4-dl-N-oxy 2,3-diacetoxymethyl-quino~aline 10 ethyl- ~ -cyan~crylate 60~
'l'he composition i9 prepared in a manner similar to that of ~ample~ 1 and 2. The cohesion strength of the cured conglo-merate a~ determined on the ~n~trument D~nstat-D1s (ultimate ben~ing strength) is 250-280 kg/cm2. The samp weight decre-ase sfter re~idence iD ~ater ~t the temperature of 37C for 28 days i8 15%. The compo~ition is i~tended for fixati~n of 1~79944 bone transplantants, filli~g o~ post-operation bone csvitie~
with a volume of up to 2 cm3.
Example 6 A compo~ition for a temporary substitution of bone tis-sue defects consists of the following components, per cent by ~ei~ht:
calcium ~luconate 30 4-uracylcarbo~yl$c acid 8 kanamycin (antlbiotic produced by Actinom~ce~ kanamyceticus) 12 ethyl- ~ -cysnacrylate 40 ethoxyethyl- ~/-cyanacrylate 10.
The composition is prepared in a manner similar to that of Exsmples 1 and 2. The co_hesion strength of the cured con-glomerate determined on the in~trument Din~tat-Dis (ultimate bending strength) ia 200-220 kg/cm2. The ~nple weight dec-reaae after reaidence in water at the temperature of 37C for 28 day~ is 23%~
The compo~ition is intended for filling post-operation bone cav-ities, ~ixation of bo~e fragments.
Ex~mple 7 A composition for a temporary substitutlon of bone tis-sue defects cons~sts of the following component~, per cent by ~elght:
calcium gluconate 30 1,4-di-~-oxy 2~3-dihydroxymethyl-~uino~aline 12 4-uracylcsrbo~ylic ac~d 8 ~1799~4 ethyl- ~ -cyanacrylate 48 ethoxyethyl- ~ -cyanacrylate 2.
The composition i~ prepared ln A manner Qimllar to t~at deacribed in ~xamples 1 and 2. The cohesion strength of the cured conglomerate as determined on the instrument Dinstat-Dis (ultimate bending strength) i9 200 to 230 kg/cm2. The ple weight decrease after re~idence in water at the tem-perature of 37C for 28 days i~ 2~%.
The compo~ition is intended for fi~tion of bone homo-transplantants, filling of post-operation bone cavities in radicsl operations on patient~ suffering ~rom chronical osteo-myelitis and the llke. The use of the composition in reconst-ruction stages of osteoplastlc operations in otolaryngology has enabled a shortened duratlon of stay of the patients in the hospitsl by 4-6 days.
~xample 8 (comparative) composition for a temporary ~ubstitution of bone t~-~ue defect~ c~n~i~ts of the following component~, ~er cent by weight:
modifled bone chips 50 ethyl- ~ -cyanacrylnte 50.
The cohe~ion ~trength of the composition detel~ined on the instrument Dinstat-Di~ (ultimate bend-ng ~trength) ia varied within the range of from 100 to 300 kg~cm2. The ~ample weight 1O~8 after residence in water at the t.mperature of 37~C for 28 day~ varies from 2 to 15~D (at the con~tant proportions of the co~lponents~.
~ield of the In~ention The present invention relates to medicine and, more spe-cifically, to a co~lposition for a temporary substitution of bone tissue defects. The composition is useful both individu-ally or in combination ~ith an ultrasonic treatment for the fixation of bone r~g~ents, fixation of bone homotransplantant at anterior cervical s oncylosis, tenpor-:ry fillin~ of bone cavities, reccvery of articular surfaces, fi~ation of on-bone implanted Pctive electrodes for a subsequent electrostimula-tion of osteo~enesis and the like.
BacXground of the Invention inown in the art are compositions for a temporary substi-tution of defects of bone tissue w~ich are based on ~-cyana-crylates and fillers, e.g. a com~,osition corrlprising ethyl-- ~ -cyanacrylate and bone chips. (In coll. "Osteosynthesis, 30ne Welding and CuttinF of ~ive Biolo~ical Tissues by Ultr~-sonic Wave Guides", ~09COW, 1970, p. 12-15, "Grthopedics, Trawn~tology and rrosthetics", Moscow, 1975, I~o. 10, p.18-23).
In prnctical use of this prior art con,position bone chips are placed onto a ~one substrate re,~aining after resection, added with ethyl- ~ -cyanacrylate Pnd under the effect of ultr~sonic treatrrJent the composition ic transforlned into a solid con~lomerate temporarily substitutin~ the bone defect.
The composition comprises 50~ by ~eight of bone chips and 50% by weight of ethyl- ~ -cyan-acrylate. 30ne chip~ compri-se an active co~ponent relative to ethyl- ~ -cyanacrylate and /
11'79944 cau~es ~n instant curing of the latter. Thi8 does not enable a preci~e metering of amounts of the components, formation of a homogeneous composition whlch, in turn, re~ults in instsble durability characteristics.
Purthermore, bone chips get rapidly impregnated with ethyl- d~-cyanacrylates ~hich results in the formation Or a monolithic conglomerate hindering regeneration of bone ti89ue.
Also known in the art i8 a composition containing 70-50~
by weight and 30-50% by ~eight of bone chips with its particles coated with an envelope of a non-toxic, ~ater~soluble and inso-luble in ethyl- ~ -cyanacrylate polymer - dextrane (cf. Veden-kov V.G., Akimova A.Ya., Bukhtiarova G.Y~., Derkach G.M., Cys' I.N. "Development of a composition for ultrasonlc welQing and meltlng-on of bone tissues baYed on modified bone shavings and ethyl-o~-cyanacrylatet'. Ultra sound and other kinds of energy in ~urgery. ~oscow, 1974, p.62-66).
Coating of particles of bone chips ~ith an envelope of a polymer soluble in water and insoluble in ethyl- ~ -cyan~-crylate hAs made it possble to ensure a more precise dosage of the components, reduce monolithic chhr~cter of the forming conglomerate.
However, the use of bone chips in the composition does not make it pos~ible to obtain a uniform blend after mi~ing of th~ components. ~or thi~ reason in the cured conglomerate there can be formed zones with an incr~fised content of bone chip~ and zones consi~ting essentially of polyethyl- ~ -cya-nacrylate. The distribution of the component~ in the cured con-glomerate affects the speed of it~ destruction under the effect of the arganism media which, in turn, ca~ slo~-down the speed of regeneration of bone tis~ue. Therefore, in the use Or modi-fted bone chips a~ 8 filler it i8 impo~sible to obtain stable reproducible re~ults as regards the ~peed o~ biodestruction of the conglomerate.
The disadvantage of the above-mentioned composition also resides in that bone chips compri~e an e~pensive product not suitable for stand~rdization. Furthermore, the use of ethyl-- ~ -cyanacrylste in this compo~ition re~ults i~ the ~ormation o~ a conglomerate resi~tant to the effect of the organism me-dia and it~ biodestruction proceeds but 810wly, wherefore the conglomerate hinders regeneration of the newly formed bone tl-ssue. In view of the above-listed disadvantages thie compo~i-tion hQs not found any suitable application in practical medi-cine.
Summsry Or the Invention It i~ an object Or the present invention to provide ~
composition for Q temporary substitution of bone tissue defects ~hich would be useful in mediacl practice and enabling reduced time of biodestruction of the cured conglomerate, thus provld-ing favourable condition~ for regeneration of bone tissue and reducing the time of treatment and rehabilitation of patients.
This object i~ Accomplished by that the compo~ition for a temporary ~ubstitution of bone ti~ue defect~ on the basls of ~ -cyanacrylic acid e~ters and a filler, according to the pre~ent invention, contains a powder-11lce filler - a salt of Galcium of an organic or inorganic acid with a particle 8~ ze of from 0.01 to 0.5 mm, the components being pre~ent in the following proportions, per cent by ~eight: -~-cyanscrylic acid esters 60 to 40 calcium ~alt of organic or inorganic acid with a partlcle size of 0.01-0.5 mm 40 to 60.
As calclum ~alts of organic or inorganic acids the compo-~ition according to the present invention caD incorporate cal-cium carbonate, calcium gluconste, calcium chloride, calcium phosphate, calcium citrate. It i8 preferable that the compo~i-tion would cont~in calcium gluconate or calcium carbonate. To impart a predetermined physiological effect to the prepara-tion, it should be a~ded with regeneration stimul~nte and anti-~eptics.
The r,reparation according to the preYent invention prefe-rably contains, as a regeneration stimulant, 4-uracylcarboxy-lic acid (orotic acid) or its derivatives in an amount of from 10 to 30% by weight.
A~ the anti~eptic the composition accordin~ to the present invention preferably incorporate~ 1,4-di-N-oxy ~,3-dlhydro~y-methylquino~aline or 1,4-di-N-oxy 2,3-d;aceto~ymethylqulno~a-line in an amo~nt of from 10 to 3~0 by weight.
A~ the composition base intended for the provisi~n of adjusted time limits of biodestruction Or the cured conglomera-te, it i8 preferred to use a nixture of ethyl- J~-cyanacrylate and etho~yethyl- ~-cyanacrylate, the componentQ being pre6cnt in the following proportions, per cent by weight:
ethyl- ~ -cyanacrylate 80 to 95 etho~yethyl- ~cyanacrylate 20 to 5.
Detsiled De~cription of the Invention The composition i8 prepared directl~ before u~e by mi~ing the compos~tion component~ at room temperature in a polyethy-lene or fluoropla~t~c vessel. After l~ixing Or the component~
paste-like mas~ 19 formed which ha~ sdherence to the bone ti~ue. The life time of the compo~ition ran&e~ ~ithin 5 to 30 minutes depending on the employed calcium salt and propor-tion~ of the components.
The p&ste-like m~ss i8 applied onto a preliminarily dried surface of the bone tissue. To accelerate the process of curing of the composition u~e can be n,ade of an ultrasonlc treatment (amplitude ~0-55Jum, frequency 26.5 kHz, treatrnent time 30-60 3econds ) .
Curing o~ the composition by the effect of ultra sound occurs within 1-2 minutes, without ultrasonic treatment - with-in 5 to 30 minutes. The u~e of calc~um ~alt in the composition according to the present ~nvention as a filler ~laXea it possib le to pro~uce ~ uniform mixture after blending of the conlpo-nents uhich, in turn, en~ures reproducible dats as regards the ~l~ed of b~odestruction of the cured conglomerate.
The u~e of the composition containing a calcium salt and a mixture of ethyl- and etho~yethyl- ~ -cyan&crylate makes it possible to reduce the duration of biode~truction of the cured con~lomerate by 0.8-2 times as co~pared with the co~iposition incorporating bone chip~ 6nd ethyl~ cyanacrylste.
To lncrease hydrophillc power of the composition, partic-les of the salt of calcium can be coated with envelopes of R
non-toxic polymer soluble in ~ater and in~oluble in ~ cyana-11799~4 crylates.
As the ~alts Or calcium use can be m de of different orga-nic and inorganic c81cium salts such as calcium carbonste, calcium chloride, calcium phosphate, calcium citrate, calclum gluconate and the like.
hs the regeneration stimulants use i8 made Or 4-uracyl-carbo~ylic scid, potassium salt of 4-uracylcsrbo~ylic acid and the like. As antiseptics use c~n be made of antibiotics or such compounds a~ 1,4-di-~-oxide 2,3-dihydroxymethylquino~a-line, 1,4-di-N-o~y 2,3-diaceto~ymethylquino~aline. The regene-ration stimulants and antiseptic~ are introdiced in an ~mount ranging from 10 to 30% by weight.
The composltlon according to the present invention has no toxic e~fect, ensures a lasting evolution of the regeneration stimulants into thetrauma zone, ret~inc bactericidsl proper-ties within 2-3 ~eek~ after the operation and provides no hindering effect on regeneration of the bone tissue.
The compo~ition for a temporary substitution of bone tis-sue defects h~s been tested in clinics on 200 patients. The composition is prepared right betore use and applied onto pre-liminarily drled surface of a bone ti~aue. The composition has thus ~een tested.
~ or filling of bone cavities in radical operations on patients suffering from chronical osteomyelitis including ~houlder osteomyelitis, femor~l osteomyelltis, tibial osteo-myelitis, i~hiatic osteomyelitis. In all c~se~ there i~ ob-serYed nealiDg of--wounds by primary e~tension; no compl~cations associated with the use of the composition according to the ~179944 pre~ent invention are observed.
The use of the composition according to the present in vention make~ it possible to avold drainaæe.
In reconstruction operations of ~rongly consolidated frac-tures, rheumatic polyarthritis, for fixation of bone fragment~
of forearm, peroneal bone, shinbone, collar bone, fixation of bone transplantant~ ~ith the use of the composition of this invention heali~g occured without complications. In none of the cases a~y secondar~ di~placement ~as observed.
In fi~ation of bone grafts to prevent micro- and macro-shiftings in reconstruction steps of osteoplastic operations of chronical otitis med~a, non-purulent disease of middle ear, chronical diseases of nasal sccessory sinuses, ma~i,llary sinus cyst, ethmoidal sinus osteoma with the use of the compo~ition according to the present invention no complications were ob-served. The use of the composition made it possib1e to reduce the duration of ~tay of the patients in the hospital by 4-6 days, as uell as to ensure a strict restoration of anatomic reliefs which is e~pecially important froln both functional and cosmetic standpoint. The composition accor~ing to the pre~ent lnvention ha~ been also tested for fixation of on-bone implan-ted electrodes for carrying out electrostimulation, as well as for fixation of ~one homotransplantant at a~terior cervical spondyoledosis.
The use of the composition acsording to tbe present in-vention has made it possible to avoid an externsl fixation of the cer~ical part of spin~l column thu~ ~llowing an early ac-tivization o~ patients. The dur&tion of ~tsy of the patients ~79944 ~n hospitEl W2S reduced b~ 2 wee~s~ No shiftings and compli~
cations due to the use of the composition were observed.
~ or a better understan~ing of the p~esent inve~tion some specific examples illustratinO the co~posi~,ion for a tempora~
r~ subs~itution of defects of bone tissue are ~iven hereln~
belo~.
Ji.ample A composition for a temporary sub~,titution of' bone tis-sue defects consists of the follo~ing componentC~ per cent by ~,eight:
cc~lcium carbona~e ~ith a par~icle size of from 0.01 ~o 0.05 mm 50 ethyl~ ~ ~cyc?n2crylate 45 ethoxyethyl~ ~ -cyanacrylate 5 ~ sterile ~eighed portion enc2psulated in de}~rane, m-'x~
ed ~ith ~ -cyan~crylic ~cid esters till the formation of a paste-like mass. ~he cohesion strength of the cured conglome~
rate determined on the instrument Dins~et Dis (ultimate bend-:ng strength) is 200 to 250 kg/cm . ~he sc~mple weight decre~se after the residence in ~ater at the ter~perature of 37C for 28 d~ys is 8,~ he composition is in-tc-n~ed for fi~c?tion of bone fragments~ bone transplantant, securing of on-bone imp~
lanted active electro~es.
~ -am~le 2 ~ co~.,.,os-tion ~or a ter~pora y su'~stitution of bone tis~
sue defects con~ists of ~he follG~ing co-~Gnents, per cent b~- weight:
calcium gluconate with a particle size of from 0~05 to 0.2 mm 60 1~7994~
.
ethyl- ~ -cyanscrylate 3~
etho~yethyl- ~ -cyanacrylate 8.
A ~terile weighed portion of calcium gluconate i8 mi~-ed with ~-cyanacrylic acid ester3 to obtain a paste-like ma~. The cohesion ~trength of the cured conglomerate deter-mined on the in~trument Dinstat Dis (ultimate bending strength i~ 230-250 kg/cm2. The sample weight decr~ase after residence in water at the temperature of 37C for 28 days i~ ~0%. The composition ~s inten~ed for fixation of bone framents, bone transplantant~, securing of on bone implanted acti~e elect-rodes, restorstion of articular surfaces.
Example 3 A composition for a temporary ~ub~titution of bone tis-~ue defects consist~ of the following components, per cent by weight:
disubstituted calcium orthophosphate 60 ethyl- ~ -cyanacrylate 40.
The composition i8 prepared follo.~.in~ the procedure si-milar to that described in Example 1 hereinbefore. The cohe-sion strength RS determined on the in~trument Dinstat Dls ~ultimate bending strength) is 250-280 kg/cm2. The sam~le weight decrease after residence in water at the temperature of 37C ~or 28 days i~ 5%. The compo~ition ls intended ior fixation of on-bone implanted actiYe electrodes, restorat~on of ~rticular surfaces.
Example 4 A compo~it~on for a temporary ~ubstitution of bone tis-sue defect~ Gonsi~ts of the ~ollowing cimponents, per cent 117g94~ ' b~ weight:
calcium gluconate 20 potassium sHlt of 4-urscyl-carbo~ylic ac~d . 20 ethyl- d -cganacrylate 40 ethoxyethyl- ~ -cyanacrylate 10.
The compo~itlon i8 prep~red in a msnner simllar to that described in E~ample~ 1 and 2. The conhesion strength of the cured.conglo~erate determined on the lnstrument Din~tat-Di~
is 200 to 220 kg/cm2. The sample u-eight decrease after re~i-dence ln water for 28 dPya st the temperature of 37C is 20%.
The composition i8 intended ror fixation of electrodes, re~-toration of articular surraces~ fi~ation of bone homotrans-plantants in the case of anterior cervlc~l spondyoledo~ 8.
Example 5 - A compo~ition for a temporar~ ~ub~titution of bone ti8-sue defects con8i8t8 of the ~-ollowing components, per cent by welght:
calcium carbonate 30 1,4-dl-N-oxy 2,3-diacetoxymethyl-quino~aline 10 ethyl- ~ -cyan~crylate 60~
'l'he composition i9 prepared in a manner similar to that of ~ample~ 1 and 2. The cohesion strength of the cured conglo-merate a~ determined on the ~n~trument D~nstat-D1s (ultimate ben~ing strength) is 250-280 kg/cm2. The samp weight decre-ase sfter re~idence iD ~ater ~t the temperature of 37C for 28 days i8 15%. The compo~ition is i~tended for fixati~n of 1~79944 bone transplantants, filli~g o~ post-operation bone csvitie~
with a volume of up to 2 cm3.
Example 6 A compo~ition for a temporary substitution of bone tis-sue defects consists of the following components, per cent by ~ei~ht:
calcium ~luconate 30 4-uracylcarbo~yl$c acid 8 kanamycin (antlbiotic produced by Actinom~ce~ kanamyceticus) 12 ethyl- ~ -cysnacrylate 40 ethoxyethyl- ~/-cyanacrylate 10.
The composition is prepared in a manner similar to that of Exsmples 1 and 2. The co_hesion strength of the cured con-glomerate determined on the in~trument Din~tat-Dis (ultimate bending strength) ia 200-220 kg/cm2. The ~nple weight dec-reaae after reaidence in water at the temperature of 37C for 28 day~ is 23%~
The compo~ition is intended for filling post-operation bone cav-ities, ~ixation of bo~e fragments.
Ex~mple 7 A composition for a temporary substitutlon of bone tis-sue defects cons~sts of the following component~, per cent by ~elght:
calcium gluconate 30 1,4-di-~-oxy 2~3-dihydroxymethyl-~uino~aline 12 4-uracylcsrbo~ylic ac~d 8 ~1799~4 ethyl- ~ -cyanacrylate 48 ethoxyethyl- ~ -cyanacrylate 2.
The composition i~ prepared ln A manner Qimllar to t~at deacribed in ~xamples 1 and 2. The cohesion strength of the cured conglomerate as determined on the instrument Dinstat-Dis (ultimate bending strength) i9 200 to 230 kg/cm2. The ple weight decrease after re~idence in water at the tem-perature of 37C for 28 days i~ 2~%.
The compo~ition is intended for fi~tion of bone homo-transplantants, filling of post-operation bone cavities in radicsl operations on patient~ suffering ~rom chronical osteo-myelitis and the llke. The use of the composition in reconst-ruction stages of osteoplastlc operations in otolaryngology has enabled a shortened duratlon of stay of the patients in the hospitsl by 4-6 days.
~xample 8 (comparative) composition for a temporary ~ubstitution of bone t~-~ue defect~ c~n~i~ts of the following component~, ~er cent by weight:
modifled bone chips 50 ethyl- ~ -cyanacrylnte 50.
The cohe~ion ~trength of the composition detel~ined on the instrument Dinstat-Di~ (ultimate bend-ng ~trength) ia varied within the range of from 100 to 300 kg~cm2. The ~ample weight 1O~8 after residence in water at the t.mperature of 37~C for 28 day~ varies from 2 to 15~D (at the con~tant proportions of the co~lponents~.
Claims (11)
1. A composition for a temporary substitution of bone tissue defects comprising esters of .alpha.-cyanacrylic acid and a powder-like filler - calcium salt of an organic or inorganic acid with a particle size of from 0.01 to 0.5 mm at the following proportions of the components, per cent by weight:
.alpha.-cyanacrylic acid esters 60 to 40 calcium salt of an organic or inorganic acid with a particle size of 0.001 - 0.5 mm 40 to 60
.alpha.-cyanacrylic acid esters 60 to 40 calcium salt of an organic or inorganic acid with a particle size of 0.001 - 0.5 mm 40 to 60
2. A composition according to claim 1, wherein as the salt of calcium use is made of calcium gluconate, calcium carbonate.
3. A composition according to claim 1, wherein a re-generation stimulant is used in an amount of 10 to 30 wt. %.
4. A composition according to claim 2, wherein a re-generation stimulant is used in an amount of 10 to 30 wt. %.
5. A composition according to claim 3, wherein as the regeneration stimulant use is made of 4-uracylcarboxy-lic acid or a derivative thereof.
6. A composition according to claim 1, wherein an antiseptic is additionally incorporated in an amount of 10 to 30% by weight.
7. A composition according to claims 2, 3 or 4, wherein an antiseptic is additionally incorporated in an amount of 10 to 30% by weight.
8. A composition according to claim 6, wherein as the antiseptic use is made of l,4-di-N-oxy 2,3-dihydroxy-methylquinoxaline or 1,4-di-N-oxy 2,3-diacetoxymethyl-quinoxaline.
9. A composition according to claims 1, 2 or 3, wherein as .alpha.-cyanacrylic acid esters use is made of a mixture of ethyl-.alpha.-cyanacrylate with ethoxyethyl-.alpha.-cyanacrylate.
10. A composition according to claims 4, 5 or 6, wherein as .alpha.-cyanacrylic acid esters use is made of a mixture of ethyl-.alpha.-cyanacrylate with ethoxyethyl-.alpha.-cyanacrylate.
11. A composition according to claim 8, wherein as .alpha.-cyanacrylic acid esters use is made of a mixture of ethyl-.alpha.-cyanacrylate with ethoxyethyl-.alpha.-cyanacrylate.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CA000404906A CA1179944A (en) | 1982-06-10 | 1982-06-10 | Composition for temporary substitution of bone tissue defects |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CA000404906A CA1179944A (en) | 1982-06-10 | 1982-06-10 | Composition for temporary substitution of bone tissue defects |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA1179944A true CA1179944A (en) | 1984-12-27 |
Family
ID=4122982
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA000404906A Expired CA1179944A (en) | 1982-06-10 | 1982-06-10 | Composition for temporary substitution of bone tissue defects |
Country Status (1)
| Country | Link |
|---|---|
| CA (1) | CA1179944A (en) |
-
1982
- 1982-06-10 CA CA000404906A patent/CA1179944A/en not_active Expired
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